67 resultados para Clinical Trials Monitorization


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Quality of life (QOL) has been extensively studied in clinical trials and in research on chronic degenerative diseases and dementia. The aim of this study was to assess the reliability and construct validity of the Brazilian version of the QOL scale in Alzheimer`s disease (AD; QOL-AD). The QOL-AD was administered to 60 patients with mild or moderate AD and to their caregivers. The construct validation was accomplished through correlations amongst total scores of patients` and caregivers` reports on patients` quality of life (PQOL and C-PQOL, respectively), and data related to cognitive impairment, depressive symptoms, functional performance, behavioral disturbances and a generic instrument of quality of life (WHOQOL-brief), as well as correlation of total score of caregivers` reports on their own quality of life (CQOL) with the measurements cited above, QOL-AD patient reports, and depressive symptoms. The reliability was high for PQOL, C-PQOL, and CQOL versions (Cronbach`s alpha = 0.80, 0.83, and 0.86, respectively). We observed significant correlations in the construct validity of all three versions regarding the variables associated with the disease and also with WHOQOL-brief. The scale took, on average, six min for each version. The results indicate reliability and construct validity of the Brazilian version of the QOL-AD in the studied sample.

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Heat-shock proteins (HSPs) are currently one of the most promising targets for the development of immunotherapy against tumours and autoimmune disorders. This protein family has the capacity to activate or modulate the function of different immune system cells. They induce the activation of monocytes, macrophages and dendritic cells, and contribute to cross-priming, an important mechanism of presentation of exogenous antigen in the context of MHC class I molecules, These various immunological properties of HSP have encouraged their use in several clinical trials. Nevertheless, an important issue regarding these proteins is whether the high homology among HSPs across different species may trigger the breakdown of immune tolerance and induce autoimmune diseases. We have developed a DNA vaccine codifying the Mycobacterium leprae Hsp65 (DNAhsp65), which showed to be highly immunogenic and protective against experimental tuberculosis. Here, we address the question of whether DNAhsp65 immunization could induce pathological autoimmunity in mice. Our results show that DNAhsp65 vaccination induced antibodies that can recognize the human Hsp60 but did not induce harmful effects in 16 different organs analysed by histopathology up to 210 days after vaccination. We also showed that anti-DNA antibodies were not elicited after DNA vaccination. The results are important for the development of both HSP and DNA-based immunomodulatory agents.

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Semiquantitative assessment of the knee by expert magnetic resonance imaging readers is a powerful research tool for understanding the natural history of osteoarthritis (OA). Several reliable semiquantitative scoring systems have been applied to large observational cross-sectional and longitudinal epidemiologic studies and interventional clinical trials. Such evaluations have enabled understanding of the relevance of disease in structures within the knee joint to explain pain and progression of OA. Compositional imaging of cartilage has added to our ability to detect early degeneration before morphologic changes are present, which may help to prevent the permanent morphologic changes commonly seen in knee OA.

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Objective: To evaluate a comparison of open-flap debridement (OFD) with or without the use of enamel matrix proteins (EMP) for the treatment of infrabony defects. Method and Materials: Ten volunteers (38 infrabony defects) were randomized to receive OFD + EMP (test site) and OFD (control site). Clinical outcomes included mean changes in Plaque Index, Gingival Index, probing pocket depth (PPD), relative attachment level (RAL), gingival recession, width of keratinized tissue, and dental mobility at baseline and at 24 months. Results: A significant reduction of 4.21 +/- 0.97 mm was observed in PPD for the OFD + EMP group (from 6.30 +/- 0.99 mm to 2.09 +/- 0.97 mm) and of 3.28 +/- 1.23 mm for the OFD group (from 6.13 +/- 0.88 mm to 2.85 +/- 1.42 mm) (P < .001). The reduction in PPD was statistically significantly greater for OFD + EMP compared to OFD (P = .03). The mean RAL decreased from 13.26 +/- 1.88 mm to 7.57 +/- 2.05 mm for the OFD + EMP group (a gain of 5.69 +/- 1.96 mm) and from 13.37 +/- 1.71 mm to 8.13 +/- 1.34 min (P < .001) for the OFD group (a gain of 5.24 +/- 1.55 mm). Gingival recession was higher it) the OFD + EMP group than in the OFD group. The mean keratinized tissue significantly decreased from 4.41 +/- 1.39 mm to 3.63 +/- 1.54 mm for OFD flap group (P < .01). Conclusion: Both treatment modalities were efficient in improving RAL and PPD. Within groups, there was a significant reduction in keratinized tissue for OFD and a significant postoperative recession for the OFD + EMP group. Infrabony defects treated with OFD + EMP showed significantly more PPD reduction when compared to OFD. (Quintessence Int 2010;41:125-134)

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The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dyssynchrony (AN/AD). Aim: Prospective cohort cross-sectional study to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in 18 children with AN/AD and cochlear implants. Material and methods: The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP`s characteristics, the threshold and amplitude of neural response were evaluated at 80Hz and 35Hz. Results: No significant statistical difference was found concerning the development of auditory skills. The ECAP`s characteristics differences at 80 and 35Hz stimulation rate were also not statistically significant. Conclusion: The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients studied. The auditory perception benefits and the possibility to measure ECAP showed that the electrical stimulation could compensate for the neural dyssynchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending a Cochlear Implant is advised. Clinical Trials: NCT01023932

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Objectives: The purpose of this study was to investigate the effect of the domestic use of a disclosing agent for denture hygiene. Materials and methods: Completely edentulous participants wearing maxillary dentures were randomly assigned to one of the three intervention groups: (1) Follow-up only (control; n = 12); (2) Oral and denture hygiene instructions (n = 10); (3) Instructions associated with the home use of a disclosing agent (1% neutral red; n = 10). Biofilm coverage area (%) over internal and external surfaces of the maxillary denture was assessed at baseline and after 14 and 90 days. Data were evaluated by generalised estimating equations based on score tests (alpha = 0.05). Results: The participants presented low changes for areas of biofilm coverage (14 days (%): internal: GI = 1.4 +/- 0.9; GII = 1.5 +/- 1.3; GIII = -0.4 +/- 0.9; external: GI = 1.4 +/- 1.5; GII = 1.5 +/- 1.4; GIII = -0.4 +/- 0.9; 90 days (%): internal: GI = 2.0 +/- 0.9; GII = 2.2 +/- 1.4; GIII = 0.3 +/- 1.0; external: GI = 2.1 +/- 1.4; GII = 2.2 +/- 1.5; GIII = 0.3 +/- 0.9). Changes were similar for the three groups (p = 0.293) and were not influenced by the test time (p = 0.218). Conclusion: It can be concluded that the home use of a disclosing agent for denture hygiene does not improve the removal of the biofilm, particularly for patients with adequate oral hygiene habits.

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To investigate the effect of the home use of a disclosing agent on the microbial composition of denture biofilm, by means of a cross-over randomized clinical trial. Two interventions were tested during 7 days each: (i) oral and denture hygiene instructions and (ii) instructions associated with the home use of a disclosing agent (1% neutral red). Eleven participants with visible biofilm deposits over their maxillary complete dentures were randomly assigned to one of the two sequences of interventions: (i) I followed by II, and (ii) II followed by I. A washout period of 7 days was established. After each intervention, samples of denture biofilm were evaluated by DNA checkerboard hybridization for the detection of Candida spp. and 17 bacterial species. Counts were low for all the tested species, and no significant difference was found between the tested interventions ( Wilcoxon test, P > 0.05). The home use of a disclosing agent does not remarkably change the composition of denture biofilm.